BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 7695415 · Received July 17, 2018

    Report

    Report Number
    1221359-2018-00451
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    November 16, 2017
    Report Date
    July 17, 2018
    Manufacturer
    ALERE SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED ON RETAINED KIT LOT 090955 WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES: (B)(6). THE KIT PERFORMED AS EXPECTED. ADDITIONALLY, QC DATA AND BATCH RECORDS FOR LOT 090955 WERE REVIEWED. RELEASE TESTING WAS VALID AND THE LOT WAS FOUND TO BE PERFORMING AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 090955 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 090955 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. IN HOUSE TESTING WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 3 (B)(6) AG RESULTS ON SERUM SAMPLES TESTED WITH 3 ALERE DETERMINE HIV 1/2 AG/AB COMBO DEVICES. SUBSEQUENT CONFIRMATORY TESTING DEMONSTRATED (B)(6) RESULTS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS PREGNANT AT THE TIME OF TESTING HOWEVER, AGE, TREATMENT, AND PATIENT OUTCOME ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536402 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH, INC. 090955 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1